Reporting to the Director, Clinical Operations, the Clinical Project Manager I is responsible for the management of clinical trials sponsored by the company, including management of contract service providers (CROs and vendors).
- Participate in CRO and vendor selection process.
- Manage the project-specific support needed by the external study team (personnel at CRO and other clinical study vendors), ensure proper adherence to clinical research regulations.
- Contribute to the development of project-specific documents (protocol, ICF), plans (e.g., Clinical Monitoring, Communication, Project Management, etc.), and other study-related documents (manuals, instructions, etc.).
- Assist in development of Case Report Forms (CRFs).
- Manage creation of study-related templates and logs by CRO.
- Manage investigative site selection process for clinical trials.
- Manage external vendors that provide systems supporting clinical trial conduct (e.g., CTMS, EDC, IWRS, eTMF, etc.).
- Track status of clinical trial deliverables.
- Support site recruitment and patient recruitment.
- Oversee the coordination and participation in Investigators’ Meetings.
- Manage clinical study timeline and budget.
- Train CRO CRAs on internal company processes.
- Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim monitoring visits, and close-out visits).
- Review and follow up on monitoring visit reports ensuring adherence to GCP/ICH.
- Manage investigational product accountability and reconciliation process.
- Contribute to the creation of internal and external memos, reports, documents, and correspondence required to properly manage and document activities on clinical studies.
- Assist in query resolution and data listings review process prior to the database lock.
- Oversee collection and management of clinical trial documentation to be filed in Trial Master File and Electronic Study Files.
- Participate in project team meetings and collaborate with other functional groups within the company (Clinical Development, Drug Safety and Pharmacovigilance, Biometrics, Clinical Research Compliance, Regulatory, QA, Pharmaceutical Operations, Legal, Medical Affairs, etc.) to achieve clinical study goals and timelines.
- Assist in preparation and QC of Clinical Study Reports.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
- Bachelor’s degree or higher in science, nursing, or equivalent.
- 7+ years of experience in biotech, pharmaceutical, or CRO industry.
- Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Experience in site monitoring and oversight of contract service providers.
- Familiarity with pharmaceutical and medical terminology.
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Publisher.
- Travel required (~10%).
- Experience in cardiology and/or nephrology therapeutic areas.
- Experience in international clinical trial operations.
As a federal contractor, Vifor Pharma, Inc. is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason, a genuine religious belief, on an individual basis in accordance with applicable legal requirements. All employees must be in compliance with Vifor Pharma, Inc.’s COVID-19 vaccine policy at the commencement of their employment.